SAS Takes the Lead in Helping Scientific Organizations Better Define Genetic Variation and Biomarkers
The Pharmaceutical Research and Manufacturers of America (PhRMA) in association with Burrill & Company, a San Francisco based life sciences merchant bank, estimate that U.S. biopharmaceutical companies spent an estimated $49.3 billion on research and development in 2004, an exponential increase over the $1.3 billion spent in 1977. However, recent recalls of high-profile medications and persistent questions about the affordability of pharmaceutical treatments have clearly demonstrated that investments in drug development are still very risky.
In its Critical Path white paper, the U.S. Food and Drug Administration (FDA) observed that traditional processes are no longer sufficient in meeting the demands of modern drug development. And with its newly released Pharmacogenomics Data Submissions guidance and the Class II Special Controls Guidance Document: Drug Metabolizing Enzyme Genotyping System, the FDA has shown its commitment toward promoting improved safety by driving the modernization of the drug development process.
To address this need for modernization, SAS, the leader in business intelligence, today announced significant upgrades and new additions to SAS(R) Scientific Discovery Solutions. These solutions establish a comprehensive scientific analysis platform that enables pharmaceutical and scientific research organizations to streamline analysis and improve the quality of results across their organizations. SAS Scientific Discovery Solutions enable drug researchers to improve their productivity and maximize their investments in research and molecular technologies. In doing so, the solutions help pharmaceutical companies refine the process of delivering safe, effective drugs and treatments.
To continue making advancements in the development of medications and to overcome criticism from consumers and government regulators alike, researchers must be able to pinpoint promising drug prospects and then establish an exhaustive understanding of each potential medication’s chemical attributes, biological responses, and human molecular impact – all in an increasingly short timeframe with fewer resources and at a reduced cost. A crucial tool in achieving this goal is the identification and validation of key, distinct biomarkers.
“It can cost more than a billion dollars and the better part of a decade to bring a promising drug prospect through development and clinical trials into the hands of the patients that need it, and even then, pharmaceutical executives still face the risk that safety issues have not been thoroughly identified,” said Laurie Rose, director of health and life sciences strategy for SAS. “Pharmaceutical companies cannot afford to take that long, and neither can the patients waiting for a medical breakthrough. SAS can provide the intelligence that scientific organizations need to identify, assess and deliver valuable targets, promising drug leads, and appropriate biomarkers consistently, enabling organizations to deliver safer drugs and treatments more quickly.”
SAS Scientific Discovery Solutions present a comprehensive scientific analysis management system that improves scientific research reliability and productivity. The components of SAS Scientific Discovery Solutions help pharmaceutical and other life sciences research organizations:
— Identify failures due to safety or efficacy issues earlier in the research process to minimize risk, and identify promising compounds sooner to increase efficiency.
— Help scientists perform investigative and biomarker research proactively to harness innovation.
— Establish a centralized analysis resource that promotes consistent decision making and streamlines the research process.
— Facilitate data preparation and analysis method customization for delivering best practices in research.
— Promote collaboration, data sharing and a multidisciplinary view of research programs to minimize time to market.
— Improve compliance features within discovery platforms to reduce regulatory issues downstream.
The suite of SAS Scientific Discovery Solutions includes SAS Research Data Management ( http://www.sas.com/industry/pharma/rdm/index.html ), a centralized data repository and analysis management platform that provides the backbone for all SAS Scientific Discovery Solutions; SAS Microarray ( http://www.sas.com/industry/pharma/mas/index.html ) for microarray data analysis; and two new software solutions available now:
— SAS Genetic Marker (http://www.sas.com/industry/pharma/gm/index.html), which enables researchers to more effectively characterize genetic variability and evaluate its association with drug response and adverse events. By improving genotype analyses during the discovery and development processes, patient populations can be characterized more effectively.
— SAS Proteomics ( http://www.sas.com/industry/pharma/proteomics/index.html ), which provides powerful, statistically based analyses to identify protein biomarkers and establish their validity as key molecular indicators for biological conditions such as disease status or drug impact. This solution equips scientific research organizations to more confidently assess metabolic profiles and establish reliable patterns for theranostic applications.
“Successful pharmaceutical and scientific institutions need to use the vast amounts of research data they gather in an intelligent, coherent way to identify toxicological issues or other safety issues, and move promising compounds through their discovery pipeline as quickly as possible,” said Irena Melnikova, senior research analyst for Life Science Insights, an IDC company. “Life Science Insights’ research consistently highlights data integration, powerful analytics and usability as key factors in getting the best from the complex, often multi-site research teams that operate in drug research. With this new release, SAS shows its continued commitment and ability to deliver an analysis platform that puts these features into the hands of scientists and technologists so they can bring safer and more effective drugs to market more efficiently.”
Improvements for existing SAS(R) Scientific Discovery Solutions
Beyond the introduction of new solutions, SAS has made significant upgrades to reinforce and extend the research productivity benefits provided by existing SAS Scientific Discovery Solutions. The new version of SAS Research Data Management improves usability and provides enhanced customization features with drop-down menus and tabs to guide users. Also, security and traceability features have been extended to the analytical processes of SAS Research Data Management, a variety of common data manipulation methods have been added, and annotation capabilities have been enhanced.
The new release of SAS Microarray adds a much broader selection of prebuilt analyses for gene expression, including new analytical procedures for quality control, normalization, pattern discovery and statistical modeling. Additionally, data preparation modules have been updated to include platforms for Affymetrix, Agilent, Genepix, Quantarray and Scanalyze.
Today’s announcement was delivered at the 30th annual SAS Users Group International (SUGI) conference. More than 3,000 SAS users from around the world attended this year’s SUGI in Philadelphia.
About SAS
SAS is the market leader in providing a new generation of business intelligence software and services that create true enterprise intelligence. SAS solutions are used at more than 40,000 sites – including 96 of the top 100 companies on the FORTUNE Global 500(R) – to develop more profitable relationships with customers and suppliers; to enable better, more accurate and informed decisions; and to drive organizations forward. SAS is the only vendor that completely integrates leading data warehousing, analytics and traditional BI applications to create intelligence from massive amounts of data. For nearly three decades, SAS has been giving customers around the world The Power to Know (R).
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